NCT00891371

Brief Summary

The purpose of this study, is to assess the effect of lanreotide Autogel 120mg on stool frequency in subjects with refractory diarrhea at day 28 (mean of last 7 days) compared to baseline.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2009

Typical duration for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

September 29, 2015

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

3.1 years

First QC Date

April 30, 2009

Results QC Date

July 17, 2015

Last Update Submit

January 11, 2019

Conditions

Diarrhea

Keywords

symptomatic treatment of patients with refractory diarrhea

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days)

    Day 28

Secondary Outcomes (5)

  • Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline

    Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56

  • Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline

    Baseline (day 1), day 28 and day 56

  • Percent Change in Mean Number of Stools Compared to Baseline

    Baseline (Day 1), Day 28 and Day 56

  • Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects

    Baseline (Day 1), Day 28 and Day 56

  • Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools

    Day 56

Study Arms (1)

lanreotide (Autogel formulation) Autogel 120mg

EXPERIMENTAL

lanreotide (Autogel formulation) Autogel 120mg

Drug: lanreotide (Autogel formulation)

Interventions

lanreotide (Autogel formulation)DRUG

Autogel 120mg

lanreotide (Autogel formulation) Autogel 120mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male/female with refractory diarrhea for at least 1 month, after normal extended work-up to exclude causes of diarrhea, not or not enough responding to standard anti-diuretics as evaluated by the investigator
  • Patient mentally fit for completing a diary

You may not qualify if:

  • Has already received a treatment with somatostatin analogues for the treatment of refractory diarrhea
  • Had a weight of stool \< 600g in a 72hrs stool collection
  • Has received a treatment with laxatives within the last week before study entry
  • Suffers from IBS with alternating bowel habits and predominant constipation, suffers from infectious and/or inflammatory gastro-enteritis (colitis ulcerosa, crohn's disease and macroscopic colitis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

OLVZ Aalst

Aalst, 9300, Belgium

Location

ZNA Antwerpen

Antwerp, 2060, Belgium

Location

AZ Sint Lucas Brugge

Bruges, 8310, Belgium

Location

UZ Antwerpen #2

Edegem, 2650, Belgium

Location

ZOL

Genk, 3600, Belgium

Location

AZ Maria Middelares

Ghent, 9000, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHC Cliniques Saint Joseph

Liège, 4000, Belgium

Location

CHU A. Vesale

Montigny-le-Tilleul, 6110, Belgium

Location

AZ Sint-Augustinus

Wilrijk, 2610, Belgium

Location

Related Publications (1)

  • Bisschops R, De Ruyter V, Demolin G, Baert D, Moreels T, Pattyn P, Verhelst H, Lepoutre L, Arts J, Caenepeel P, Ooghe P, Codden T, Maisonobe P, Petrens E, Tack J. Lanreotide Autogel in the Treatment of Idiopathic Refractory Diarrhea: Results of an Exploratory, Controlled, Before and After, Open-label, Multicenter, Prospective Clinical Trial. Clin Ther. 2016 Aug;38(8):1902-1911.e2. doi: 10.1016/j.clinthera.2016.06.012. Epub 2016 Aug 8.

    PMID: 27423779DERIVED

MeSH Terms

Conditions

Diarrhea

Interventions

lanreotide

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Medical Director, Gastroenterology
Organization
Ipsen
clinical.trials@ipsen.com
clinical.trials@ipsen.com

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 1, 2009

Study Start

July 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2013

Last Updated

January 15, 2019

Results First Posted

September 29, 2015

Record last verified: 2019-01

Locations

BE(11)